October 2016 Professional Development Meeting

The next Professional Development meeting will be held on

Thursday, October 27, 2016

Please REGISTER to confirm your attendance.

PD Presentation:  

We Did It! But no one said it would be easy…

By Mandy Dirickson

UT Southwestern Medical Center in Dallas, TX is the only Joint Commission Comprehensive Stroke Center with an initial survey of no deficiencies in Texas and the only one in the country with a 2 hospital campus. As a large state owned academic medical center, UT Southwestern had some unique challenges to the path of comprehensive quality stroke care but still achieved the distinction to be the first designated Comprehensive Stroke Center  in Dallas, Texas. Mandy, a core member of the team, was the first advanced practice nurse hired for program. She will share the lessons learned in this journey that may help you with other quality initiatives.

mandy-2015Mandy Dirickson, MS, APRN, ANP-C, SCRN is the Stroke Outreach Coordinator, APN Supervisor and Senior Clinical Provider for the University of Texas Southwestern Medical Center, Department of Neurology and Neurotherapeutics, Stroke Division.

A native of Texas, Amanda received both her Bachelors and Masters of Science in Nursing from Texas Woman’s University. She is currently seeking a PhD in nursing from UT Tyler.  In 2008, she joined UT Southwestern Medical Center and began work with the institutional leadership on building the University’s Comprehensive Stroke Center.  It remains the only Joint Commission certified Comprehensive Stroke Center in North Texas. Along with clinical duties of care and treatment of stroke patients, Mandy’s role includes clinical leadership to the program and coordination of stroke outreach, including telestroke services. She is also the co-director of the Annual UT Southwestern Stroke Symposium.

Mandy speaks often to layperson, paramedic, nursing, and physician audiences on acute stroke care, treatment and prevention. She is a course instructor also for the El Centro Paramedic Program stroke class and CareFlite’s Certified EMT Critical Care Neurology course locally. She has chaired the North Central Texas Trauma Regional Advisory Council’s stroke sub-committee and is an active member of the American Association of Neuroscience Nurses. She has presented nationally on stroke topics both at the American Association of Nurse Practitioner Annual Conference and the American Association of Neuroscience Nurses Annual Meeting. Mandy is the PI for the HER STROKE study, which is supported by the St Paul Foundation.


Tutorial Topic:

Transition Made Easy by sniX for ISO 9001 Based Standards

By Cindy Soltis-Stroud

sniX is a revolutionary software that puts the process and process owners at the heart of your management system.  Requirements of the standard and the process approach are built in for easy implementation and sustainability.  Reduce documentation, increase effective utilization of resources year after year with immediate return on investment.

cindyCindy Soltis-Stroud is CEO of Cogent Global Performance Solutions, inc.  Cindy is a certified IATF auditor with over 18 years of third party auditing experience.  She recently presented at the 2016 AIAG Quality Summit on the corrective action panel with TI Automotive and Volvo.  She and her team were selected by Honda to exhibit sniX at the lean summit in May of 2017 which is limited to unique innovative tools for improvement.  SniX was also selected as an exclusive  product presentation at the ASQ  transition summit in Pittsburgh, November 2016.


PD MEETING NOTE:

Normally, Professional Development (PD) meetings are always the fourth Thursday of every month.  There are no meetings in June, July, August (summer break) and December (after Thanksgiving).  PD Presentations are normally given between 5:30 and 6:30 PM: 45 minutes for the presentation and about 15 Minutes of Q&A at the end.

Interested in giving a presentation or tutorial at one of our future PD meetings?  Contact the ASQ Dallas Chair (ASQDallasChair at gmail dot com).

25th Annual Quality Audit Conference

Don’t miss out on attending the renowned Annual ASQ Audit Conference
in Memphis on October 20-21, 2016.

PeabodyJoin us for the 25th Annual Quality Audit Conference, sponsored by the ASQ Quality Audit Division at the world renowned Peabody Hotel, in Memphis Tennessee, the home of Elvis Presley.

 

New Horizons in Auditing:
Controlling Risk to Improve Performance, Processes, and Systems

Conference Overview:

Technological innovation matched with innovative auditing approaches and techniques, significant changes in evolving standards, new foundations and new synergies between disciplines—all present New Horizons for the quality professional of the 21st century.

With these new horizons, come new challenges and opportunities for auditing. This conference focuses on the auditor’s role in identifying quality issues to improve performance, processes and systems, and controlling risk specific to new horizons in auditing

The conference program includes four tracks for assisting auditors to help unlock their potential. These are:

  1. Innovation and auditing new technological advances
  2. Changing Standards (e.g. ISO 9001:2015)
  3. New foundations in Quality and the tools that go with them: applying current Quality tools to new domains; applying new Quality tools to new and existing domains
  4. Synergies and Serendipities: merging existing strategies, tools and techniques to create and discover something new and powerful

Who Should Attend?

The 2016 Audit Conference is a great venue for learning and networking opportunities for auditors, audit program managers, quality managers, quality directors and individuals who have leadership responsibilities and are actively involved in the process of auditing and performance appraisal, and process improvement.

TAKE FULL ADVANTAGE OF THESE “extraordinary” audit conference values

all included in the conference fee of $895:

  • SPECIAL “ASQ Audit Conference” Hotel Room Rate = $ 175 Per Night – Double Occupancy
  • Keynote Addresses presented by Leaders in the Quality Profession!
  • Free access to all PowerPoint Conference Presentations
  • Free Conference Commemorative Bag
  • Free Conference “LOGO” Cloisonné Pin and Other Goodies
  • Continental Breakfasts
  • Mid-Morning & Mid Afternoon Refreshments & Networking Opportunities
  • Waited Lunches
  • Exceptional Thursday evening Conference Opening “Gala” Reception with extensive Hors d’ Oeuvres and food buffet with Carving Stations, great entertainment & Networking Opportunities
  • Distinctive Prize Raffles & Book Giveaway throughout the conference – Prizes Galore!!
  • Meet with the Audit Division officers, Division Management Committee & 2016 Conference Committee!
  • Networking Opportunities throughout the duration of the Conference!
  • Sponsor Gallery Highlighting Leading Profession Organizations as Conference Sponsors, Available For Networking and Product/Services Discussions!
  • Opportunities to Discuss Current Issues with Quality Authors, Professionals, and Specialists from Around the World!
  • Conference “Bookstore” with “Barnes & Noble” Atmosphere, Featuring Current Books On All Facets Of Quality, While Serving Exotic Coffee, Teas & Pastries, And Conference Rates on books and Audit Division LOGOWEAR.
  • Audit Division Annual Business Meeting

REGISTER NOW AND WE WILL SEE YOU AT THE PEABODY HOTEL IN MEMPHIS, TN.

 

September 2016 Professional Development Meeting

The next Professional Development meeting will be held on

Thursday, September 22, 2016.

Please REGISTER to confirm your attendance.

PD Presentation:  

Master the Art of Social Selling with LinkedIn

By Terry Sullivan

Terry Sullivan

Terry is an Integrated Marketing and Social Selling Strategist, LinkedIn Trainer & Speaker.

Holder of an MBA from Texas State University, Terry received his Social Media Marketing Certification from Splash Media University, one of the nation’s premier Social Media training companies.

Before he founded BUZZPRO in 2012, Terry Sullivan was Director of Marketing for Verizon Communications where he launched many successful national marketing programs that gained more than 456,000 new customers and reduced churn by more than 6% annually, in spite of multiple price increases and competitor product launches.

Why should you use LinkedIn?

LinkedIn is the proven #1 ranked online business-networking tool that gives business professionals and companies the ability to connect, demonstrate their skills, services and products, and develop meaningful business relationships and sales. With more than 414 million users worldwide,

LinkedIn provides unlimited networking and business-building opportunities. Widely considered to be a Guru of LinkedIn, Terry has trained more than 6,200 business leaders and owners across the nation on how to create their very own unique online brand that gets results. His inspiring LinkedIn training programs focus on branding, keyword optimization and Social Selling strategies that help his customers tap into the world of Social Media to get more prospects, leads and clients.

In his presentation, Terry will show you how use LinkedIn to take advantage of the immense opportunities this powerful platform offers as a personal branding and marketing tool to achieve your business goals.

In Terry’s presentation, you will learn how to…

✓ Connect With The Right People – Quickly and easily connect with the decision makers in the companies you want to work with.
✓ Build Better Leads Faster – Create your own personal lead list of people who will automatically trust you.
✓ Manage Your Contacts – Use LinkedIn as a contact relationship management (CRM) tool to easily keep track of your key contacts, correspondence, phone conversations and more.
✓ Build a Great Reputation – Have professional on LinkedIn eager to receive your marketing messages, connect with you and ask you for your products and services.


Tutorial Topic:

Using Inter-Company Cooperation to Improve Quality and Reduce Cost

By Debbie Roper

droperDebbie was the Stroke Coordinator at the first Hospital in Nevada to receive Primary Stroke Center Certification. She then moved back to Texas and was the Stroke Coordinator that got the first hospital in Tarrant county Stroke Certified. In 2014 when the 11th hospital in the HCA North Texas Division got Stroke Certified she became the first person in the United States to get an entire system Stroke Certified. As part of this system accomplishment she was able to get 11 separate hospitals to adopt system wide processes and documentation. As part of this project over 100 rural hospitals agreed to send their stroke patients to the HCA system known as Texas Stroke Institute.

She is now working with Twine Clinical Consulting and the Texas Organization of Rural and Community Hospitals TORCH to raise the quality of stroke care in rural areas through a grant from Genentech.

Debbie has recognized the need in other industries such as Electronic Manufacturing to adopt this collaborative approach to improve the effective implementation of Quality Systems and training. She will explore the similarities and differences between these 2 industries in hopes that we can all use her knowledge and ability to “think outside the box” to improve our company’s Quality through cooperation and effective communication.


PD MEETING NOTE:

Normally, Professional Development (PD) meetings are always the fourth Thursday of every month.  There are no meetings in June, July, August (summer break) and December (after Thanksgiving).  PD Presentations are normally given between 5:30 and 6:30 PM: 45 minutes for the presentation and about 15 Minutes of Q&A at the end.

Interested in giving a presentation or tutorial at one of our future PD meetings?  Contact the ASQ Dallas Chair (ASQDallasChair at gmail dot com).

Culture of Quality + Quality Metrics = How Do You Measure Up?

Half-Day Professional Conference
8:00 AM –12:00 PM
Friday, September 9th, 2016
The Mary Kay Building ●16251 Dallas Parkway ●Addison, TX 75001
Registration, Networking and Continental Breakfast Begin at 8:00 AM
Cost: $45*/person –Must register in advance Register Now

PresBy

Agenda
8:00 Registration, Networking & Continental Breakfast
8:30 Opening/Welcome –Tim Parrent, Vice Chair-PCPC QAC,

      Regional Councilor-ASQ FD&C

Culture of Quality

Culture of Quality –Beth Lange, EVP Science and Chief Scientist, PCPC
Culture of Quality Case Studies
• The Amway Quality Culture Journey –Tom Hines, QA Manager, Amway
• Lab Excellence Quality Culture Journey –David Long, Quality Dir., Edgewell

10:00 –10:30 Break

Quality Metrics

FDA’s New Guidance & An Industry Perspective –Steve Greer, Corporate QA External Engagement, Proctor & Gamble

How Do You Measure Up?

FDA Inspections –Thomas Arista, Consumer Safety Officer / Field Investigator, FDA (invited)

12:00 Adjourn

May 2016 Professional Development Meeting

The next Professional Development meeting will be held on

Thursday, May 26, 2016.

Please REGISTER to confirm your attendance.

PD Presentation:  

The Two Big D’s: Data Analysis and Data Integrity

By Danny Aguilar

Data integrity has been a hot topic recently and has gained wide attention due to increased regulatory issues. This presentation emphasizes the importance of Data Integrity. It also explores the relevance of Data Analysis in the context of enhancing processes and quality system. Moreover, good documentation practices will also be covered.


Tutorial Topic:

Conducting a Robust Failure Investigation

By Danny Aguilar

This presentation focuses on methods and techniques to conduct robust and effective failure investigation. Additionally, a case study will be explored to gain a practical application of this tool and technique.


Danny Aguilar Bio:

As the Principal Consultant of Quality Eagle Consulting, Danny Aguilar brings over 15 years of experience and expertise in the areas of process improvement, quality auditing, compliance, quality engineering, six sigma, project management, etc. in the biological, pharmaceutical, biopharmaceutical, medical devices and automotive industries.

Academically, Mr. Aguilar holds the following degrees:

• BS Chemical Engineering – Saint Louis University, Baguio City Philippines
• MS Management Engineering – University of Bridgeport, Bridgeport, CT
• Master in Business Administration – University of Tampa, Tampa, FL

Additionally, Danny is a Senior Member of ASQ. He is an ASQ Certified Quality Engineer, ASQ Certified Quality Auditor and Johnson and Johnson Process Excellence Six Sigma Black Belt. His work experience includes working for Johnson and Johnson, Bausch and Lomb and Sanofi. In his spare time, Danny enjoys volunteering and film making.


PD MEETING NOTE:

Normally, Professional Development (PD) meetings are always the fourth Thursday of every month.  There are no meetings in June, July, August (summer break) and December (after Thanksgiving).  PD Presentations are normally given between 5:30 and 6:30 PM: 45 minutes for the presentation and about 15 Minutes of Q&A at the end.

Interested in giving a presentation or tutorial at one of our future PD meetings?  Contact the ASQ Dallas Chair (asqdallaschair at gmail dot com).

April 2016 Professional Development Meeting

The next Professional Development meeting will be held on

Thursday, April 28, 2016.

Please REGISTER to confirm your attendance.

PD Presentation:  

ISO 9001:2015 Revision – the “Highlights Reel”

By Mary McDonald

This presentation highlights the changes for the ISO 9001:2015 standard, including what the major changes are, and how you can prepare your organization for transition.

Mary covers the shift from Top Management to Leadership; the impact of Context on future audits and implementation; Risk-Based Thinking, internal communication, as well as the transition schedule.

She’ll also bring her real-world experiences to bear as a consultant helping organizations to transition smoothly, and as a registrar auditor assessing organizations ready to transition.


BIO: Mary McDonald is a seasoned Quality/Environmental/Health and Safety professional MaryMcDonald2016with over 30 years’ experience in implementing Management Systems around the world.  Her BS in Environmental Engineering and MS in Industrial Administration ensures that she can work form the factory floor to the C-suite with equal ease.  Her involvement in the US Technical Advisory Groups for both ISO 9001 and ISO 14001 since 1995 ensures that she is not only aware of WHAT the changes are, but WHY those changes were made. In addition to implementing ISO systems, Mary is a certified Lean and Kaizen facilitator and consultant, and is holds certifications in OHSAS 18001, RoHS, and industry-specific standards including TL 9000, AS 9100, and ISO/TS 16949.

She gives back to our profession through regular speaking engagements to ASQ sections and conferences, volunteering as a MBNQA Examiner (3 times) and writing articles for inclusion in industry publications.

Her husband and grown children live in Austin; Mary lives in various hotels, with occasional wardrobe swaps in Austin.

Tutorial Topic:

TBD

By Mary McDonald


PD MEETING NOTE:

Normally, Professional Development (PD) meetings are always the fourth Thursday of every month.  There are no meetings in June, July, August (summer break) and December (after Thanksgiving).  PD Presentations are normally given between 5:30 and 6:30 PM: 45 minutes for the presentation and about 15 Minutes of Q&A at the end.

Interested in giving a presentation or tutorial at one of our future PD meetings?  Contact the ASQ Dallas Chair (asqdallaschair at gmail dot com).

ASQ BioMedical Division and FDA Medical Device Industry Coalition – Big Event – April 15, Dallas, TX

Big Event 2016 – Final Meeting Agenda Posting

Quality System Survival: Success Strategies for Production & Process Control,   and CAPA

Date and Time: April 15, 2016 from 8 a.m. to 5 p.m.

Location: Courtyard Dallas DFW Airport North/Grapevine, 2200 Bass Pro Court, Grapevine, TX 76051 USA.  Telephone (817) 251-9095

Every two years FMDIC, with the participation of ASQ Biomedical Division, hosts the “Big Event”, an educational forum for members of the medical device industry to gain more knowledge on how to best implement quality system practices in their organization to ensure product quality and safety, while meeting the requirements of the FDA regulations.  This year’s event focuses on Production and Process Control combined with CAPA, which remain key warning letter citations for many firms.  This event is an all-day seminar which will feature speakers from FDA, academia and industry giving their thoughts on how to best manage these processes in a manufacturing organization.

Because there is a limited capacity for this event, we recommend advanced registration. Click on the link below to register online and reserve your seat.  Be sure to contact the Marriott Courtyard Dallas – DFW Airport North Hotel to reserve your guest room, if needed, under the FMDIC, Inc. room block to receive a reduced rate as well. 

Registration Fee: Industry $300, Government with ID $200, and Student registration with ID $50. To register online, please visit https://www.123signup.com/register?id=pnrxz. As an alternative, send registration information including the registrant’s name, title, organization, address, telephone and fax numbers, and email address (for each registrant), along with a check or money order (covering all registration fees) payable to FMDIC, Inc., to FMDIC Registrar, 4447 North Central Expressway, Suite 110, PMB 197 Dallas, TX 75205.

If you need special accommodations due to a disability, please contact Staci McAllister at least 7 days in advance at Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204, 214-253-5259, FAX: 214-253-5314, email: Staci.McAllister@fda.hhs.gov.

FMDIC is a non-profit coalition, composed of key employees of the FDA offices in Dallas, officials from the Texas Department of Health, academic members as well as individuals from professional and trade associations representing the medical device industry, including ASQ and the ASQ Biomedical Division.  FMDIC was formed to promote communication, education and cooperation between the regulators and the regulated industry.